Smith & Neph: D-RAD Self-Tapping Locking Screws (Lot 17GM04522) may have over-tolerance threads causing improper fracture fixation. Affected patients should contact manufacturer for details.
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
Smith & Nephew is recalling a specific batch of D-RAD Self-Tapping Locking Screws used in distal radius fracture repairs. The screws in this batch were machined slightly too large, which could lead to improper bone fixation and potential complications during healing.
The screws in this batch were machined slightly too large (0.002-0.003 inch over tolerance), which could cause improper thread engagement with bone. This might lead to screw loosening or failure during healing, potentially causing pain or delayed fracture repair.
Patients who received the D-RAD Self-Tapping Locking Screws with Lot Number 17GM04522 for distal radius fractures are affected. Medical professionals using this specific batch for surgical procedures are at higher risk.
Check for the Lot Number 17GM04522 on the packaging of D-RAD Self-Tapping Locking Screws (2.4MM x 10MM, sterile, REF 74692410) used in distal radius fracture kits.
Look for Lot Number 17GM04522 on the packaging of the D-RAD Self-Tapping Locking Screws.
The screws in this batch were machined slightly too large (0.002-0.003 inch over tolerance), which could cause improper thread engagement with bone.
Check for Lot Number 17GM04522 on the packaging of D-RAD Self-Tapping Locking Screws (2.4MM x 10MM, sterile, REF 74692410) used in distal radius fracture kits.
The recall record does not specify a remedy, so contact Smith & Nephew directly for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1317-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1317-2018 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
